Your One Key Metric: Medical Devices

Every startup has one key metric to grow their business to the next level. 

In applications requiring FDA certification, revenue is not the key metric, but rather FDA approval is.

For medical device companies the key metric is cycle time through the 510K application and approval process. 

The purpose of a 510k submission is to demonstrate that your medical device is at least as safe and effective as an existing medical device on the market today.

The cycle time for approval varies based on type of device and ranges anywhere from 50 to 300 days.

Your key metric compares your performance against the standard cycle time for your type of device.

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